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Etravirine Pharmacokinetics in HIV-Infected Pregnant Women

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Title: Etravirine Pharmacokinetics in HIV-Infected Pregnant Women
Authors: Mulligan, N
Schalkwijk, S
Best, BM
Colbers, A
Wang, J
Capparelli, EV
Moltó, J
Stek, AM
Taylor, G
Smith, E
Hidalgo Tenorio, C
Chakhtoura, N
Van Kasteren, M
Fletcher, CV
Mirochnick, M
Burger, D
Item Type: Journal Article
Abstract: BACKGROUND: The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women. METHODS: IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL). RESULTS: Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC0-12 was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19-4.25) and no perinatal transmission occurred. CONCLUSION: Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available. CLINICAL TRIAL REGISTRATION: The IMPAACT protocol P1026s and PANNA study are registered at ClinicalTrials.gov under NCT00042289 and NCT00825929.
Issue Date: 4-Aug-2016
Date of Acceptance: 21-Jul-2016
URI: http://hdl.handle.net/10044/1/39582
DOI: http://dx.doi.org/10.3389/fphar.2016.00239
ISSN: 1663-9812
Publisher: Frontiers Media
Journal / Book Title: Frontiers in Pharmacology
Volume: 7
Copyright Statement: © 2016 Mulligan, Schalkwijk, Best, Colbers, Wang, Capparelli, Moltó, Stek, Taylor, Smith, Hidalgo Tenorio, Chakhtoura, van Kasteren, Fletcher, Mirochnick, Burger and on behalf of the PANNA Network and the IMPAACT 1026s Study Teams. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Sponsor/Funder: UMC St Radboud
Funder's Grant Number: N/A
Keywords: HIV
etravirine
perinatal transmission
pharmacokinetics
pregnancy
1115 Pharmacology And Pharmaceutical Sciences
Publication Status: Published
Article Number: 239
Appears in Collections:Department of Medicine
Faculty of Medicine



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